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Immediate Effects on Gait and Spasticity After the Use of Passive Kinesiotherapy Equipment in the Lower Limbs of Neurological Patients

F

Fernanda Trubian

Status

Invitation-only

Conditions

Spasticity
Cerebral Palsy
Tetraparesis
Hemiparesis
Paraparesis
Spastic Gait

Treatments

Device: Passive mobilization using a device

Study type

Interventional

Funder types

Other

Identifiers

NCT06696040
83118724.0.0000.5341

Details and patient eligibility

About

Undergo assessment of muscle tone (Ashworth Scale), gait (BAIOBIT) and risk of falling (Timed Up and Go) before using the device; Use the device on the spastic lower limb(s) for 30 minutes; Go through the same assessment carried out previously.

Enrollment

80 estimated patients

Sex

All

Ages

9+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • agree and sign the Free and Informed Consent Form or signature of the person responsible
  • individuals with spasiticity (hemiparetic, paraparetic, tetraparetic and hemiparetic children with cerebral palsy)

Exclusion criteria

  • over 18 years old whose ability to sign the Free and Informed Consent Form is compromised, or who understand it, but are not responsible for signing the Free and Informed Consent Form
  • present cardiovascular, neurological, musculoskeletal instability or other condition(s) that interfere with the use or positioning of the device or gait assessment
  • present cognitive deficits that interfere with understanding the ICF and/or understanding how to carry out the protocol
  • For the children's group, participants who: 1) are under 8 years of age and/or over 13 years of age will be excluded; 2) no person responsible for signing the TCLE; 3) present cognitive deficits that interfere with understanding the ICF and/or understanding how to carry out the protocol

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

Pre-intervention and immediate post-intervention
Experimental group
Treatment:
Device: Passive mobilization using a device

Trial contacts and locations

1

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Central trial contact

Fernanda Trubian, Master's degree in health scie

Data sourced from clinicaltrials.gov

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